FDA UDI
In Commercial Distribution
🇺🇸 United States
CooperSurgical®
DI: 00888937027815
·
Model: DP-MCV01
·
Coopersurgical, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CooperSurgical®
- Primary DI
- 00888937027815
- Version / Model
- DP-MCV01
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-01
- Public Version
- 1
- Public Version Date
- 2026-04-09
- Public Version Status
- New
- Public Device Record Key
- 5f2b1fc0-4d56-40c7-93d4-281f5503f0dc
Device Description
DOPPLER MONITOR CABLE-VERIFIER
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | Cardiovascular | 870.2100 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
| JOP | Transducer, Ultrasonic | Cardiovascular | 870.2880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60416 | Ultrasonic blood flowmeter transducer electronic-signal simulator | A portable instrument intended to be used to mimic the electrical output of an ultrasonic blood flowmeter transducer to test an ultrasonic blood flowmeter and/or transducer cable. It typically includes an exposed piezoelectric crystal which when rubbed produces a Doppler signal response in the connected flowmeter. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888937027815 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110347 | 000 |